// Compliance and regulatory navigation for regulated industries. Use when identifying compliance requirements or assessing regulatory risks.
| name | foundations-regulatory |
| description | Compliance and regulatory navigation for regulated industries. Use when identifying compliance requirements or assessing regulatory risks. |
The Regulatory Agent navigates complex compliance landscapes for startups operating in regulated industries, minimizing legal risk while maintaining operational velocity. This specialist agent is activated only when entering regulated markets, not for standard SaaS companies.
Primary Use Cases: Compliance mapping, risk assessment, licensing, data privacy, ongoing monitoring.
Lifecycle Phases: Market entry (regulated industries), product launch, expansion to new jurisdictions.
Identify applicable regulations and create comprehensive compliance checklist with deadlines.
Workflow:
Identify Applicable Regulations
Map Jurisdiction Requirements
Classify by Criticality
Timeline Assessment
Output Template:
Compliance Checklist
Business Context:
โโโ Industry: [Healthcare/Finance/Education/Other]
โโโ Business Model: [B2B/B2C/Marketplace]
โโโ Data Collected: [PII, PHI, financial, children's data]
โโโ Jurisdictions: [US, EU, specific states]
โโโ Company Stage: [Pre-launch/Launched/Scaling]
Applicable Regulations:
Industry-Specific:
1. [Regulation Name] (e.g., HIPAA)
โโโ Applicability: [Who must comply]
โโโ Requirements: [Key obligations]
โโโ Deadline: [When compliance required]
โโโ Penalty: $X fine per violation, potential criminal charges
โโโ Effort: [Low/Medium/High]
โโโ Cost: $X (legal, consulting, implementation)
โโโ Priority: CRITICAL / HIGH / MEDIUM / LOW
2. [Regulation]...
Data Privacy:
1. GDPR (if EU customers)
โโโ Applicability: Any EU resident data processing
โโโ Requirements: Consent, data minimization, right to deletion, DPO, DPIA
โโโ Deadline: Before collecting EU data
โโโ Penalty: Up to 4% global revenue or โฌ20M
โโโ Effort: High (requires engineering + legal + process changes)
โโโ Cost: $50K-$150K (legal + implementation)
โโโ Priority: CRITICAL (if EU customers)
2. CCPA/CPRA (if California customers)
โโโ Applicability: $25M+ revenue OR 50K+ CA consumers OR 50%+ revenue from selling data
โโโ Requirements: Privacy policy, opt-out rights, data deletion, no discrimination
โโโ Deadline: Immediate if thresholds met
โโโ Penalty: $2,500 per violation ($7,500 intentional)
โโโ Effort: Medium
โโโ Cost: $20K-$50K
โโโ Priority: HIGH (if applicable)
3. [Other privacy law]...
Sector-Specific:
1. [Regulation]: [Requirements]...
Compliance Timeline:
Immediate (<30 days):
- [ ] [Compliance item]: [Brief description]
- [ ] [Compliance item]: [Brief description]
Short-term (30-90 days):
- [ ] [Compliance item]: [Brief description]
- [ ] [Compliance item]: [Brief description]
Medium-term (3-12 months):
- [ ] [Compliance item]: [Brief description]
Long-term (12+ months):
- [ ] [Compliance item]: [Brief description]
Total Compliance Cost: $X - $Y
Total Timeline: X months to full compliance
Evaluate compliance risks by severity, likelihood, and impact.
Workflow:
Evaluate Violation Penalties
Assess Enforcement Likelihood
Calculate Impact
Prioritize by Risk
Design Mitigation Strategies
Output Template:
Regulatory Risk Matrix
Risk Assessment:
| Risk Area | Severity | Likelihood | Risk Score | Priority |
|-----------|----------|------------|------------|----------|
| [Risk 1] | 5 | 4 | 20 | CRITICAL |
| [Risk 2] | 4 | 3 | 12 | HIGH |
| [Risk 3] | 3 | 3 | 9 | MEDIUM |
| [Risk 4] | 2 | 2 | 4 | LOW |
Critical Risks (Score โฅ15):
1. [Risk Area]: [Description]
โโโ Severity: 5/5 - [Existential threat/Major fines/Shutdown]
โโโ Likelihood: 4/5 - [Why likely to occur]
โโโ Penalties: [Financial, operational, reputational, criminal]
โโโ Recent Enforcement: [Examples of companies penalized]
โโโ Mitigation Strategy: [How to address]
โโโ Cost to Mitigate: $X
โโโ Timeline: X weeks
โโโ Owner: [Legal/Engineering/Operations]
2. [Risk]...
High Risks (Score 10-14):
1. [Risk Area]: [Description]
โโโ Severity: X/5
โโโ Likelihood: X/5
โโโ Mitigation: [Strategy]
โโโ Timeline: X weeks
Medium Risks (Score 5-9):
- [Risk]: [Brief mitigation]
- [Risk]: [Brief mitigation]
Low Risks (Score <5):
- [Risk]: Accept and monitor
- [Risk]: Accept and monitor
Risk Mitigation Roadmap:
Phase 1 (Weeks 1-4): Critical Risks
โโโ [Risk 1]: [Mitigation action]
โโโ [Risk 2]: [Mitigation action]
โโโ Budget: $X
โโโ Owner: [Legal team + Engineering]
Phase 2 (Weeks 5-12): High Risks
โโโ [Risk 3]: [Mitigation action]
โโโ [Risk 4]: [Mitigation action]
โโโ Budget: $X
โโโ Owner: [Operations team]
Phase 3 (Months 4-12): Medium Risks
โโโ [Risk 5]: [Monitoring + mitigation if needed]
โโโ Budget: $X
โโโ Owner: [Compliance officer]
Ongoing Monitoring:
- Quarterly risk reassessment
- Track regulatory changes
- Monitor enforcement trends
- Update mitigation strategies
Insurance Recommendations:
โโโ Cyber Liability: $X coverage (data breaches, privacy violations)
โโโ D&O Insurance: $X coverage (personal liability for executives)
โโโ Professional Liability: $X coverage (errors and omissions)
โโโ Total Premium: $X/year
Research required licenses, application processes, and create licensing roadmap.
Workflow:
Research Required Licenses
Map Application Processes
Estimate Time to Obtain
Calculate Total Costs
Create Licensing Roadmap
Output Template:
Licensing Roadmap
Required Licenses:
Pre-Launch (Before Operating):
1. [License Name]
โโโ Jurisdiction: [Federal/State/Local]
โโโ Issuing Authority: [Agency name]
โโโ Application Requirements:
โ โโโ Forms: [List]
โ โโโ Documentation: [Corporate docs, financials, background checks]
โ โโโ Prerequisites: [Other licenses, bonds, insurance]
โโโ Processing Time: X weeks/months
โโโ Fees:
โ โโโ Application: $X
โ โโโ Background Check: $X
โ โโโ Total: $X
โโโ Renewal: Every X years ($X fee)
โโโ Ongoing Obligations: [Reporting, audits, continuing education]
โโโ Critical Path: YES - Blocks launch
โโโ Next Steps: [Apply by date X]
2. [License]...
Growth Phase (When Scaling):
1. [License Name]
โโโ Trigger: [When required - e.g., $X revenue, X employees, specific services]
โโโ Processing Time: X months
โโโ Cost: $X
โโโ Lead Time: Start application X months before trigger
Expansion Licenses (New Jurisdictions):
| State/Country | License Required | Processing Time | Cost | Priority |
|---------------|------------------|-----------------|------|----------|
| [State 1] | [License] | X months | $X | High |
| [State 2] | [License] | X months | $X | Medium |
| [State 3] | [License] | X months | $X | Low |
License Application Timeline:
Month 1-2:
โโโ Prepare documentation (corporate records, financials, policies)
โโโ Background checks for key personnel
โโโ Obtain prerequisite licenses or bonds
โโโ Cost: $X
Month 3-4:
โโโ Submit applications for [License 1], [License 2]
โโโ Respond to information requests
โโโ Pay application fees
โโโ Cost: $X
Month 5-6:
โโโ Final review and approval
โโโ Receive licenses
โโโ Implement compliance processes
โโโ Cost: $X
Total Licensing Costs:
โโโ Pre-Launch: $X (one-time)
โโโ Ongoing: $X/year (renewals + maintenance)
โโโ Expansion: $X per new jurisdiction
Critical Dates:
- [Date]: Submit [License] application
- [Date]: Expected [License] approval
- [Date]: Launch allowed (assuming approvals)
Design and implement data privacy frameworks compliant with global regulations.
Workflow:
Select Applicable Frameworks
Implement Consent Flows
Design Data Retention
Build Breach Response Protocol
Document Privacy Practices
Output Template:
Data Privacy Compliance Blueprint
Applicable Frameworks:
โโโ GDPR: YES (EU customers or employees)
โโโ CCPA/CPRA: YES (California customers, meets thresholds)
โโโ HIPAA: NO (not handling PHI)
โโโ COPPA: NO (no users under 13)
โโโ SOC 2: Recommended for B2B credibility
Data Inventory:
| Data Type | Source | Purpose | Retention | Sensitivity |
|-----------|--------|---------|-----------|-------------|
| Email, name | Signup | Account management | Account lifetime + 1 year | PII |
| Payment info | Stripe | Billing | Transaction + 7 years | Financial |
| Usage data | Product | Analytics | 2 years | Non-PII |
| Support tickets | Zendesk | Customer support | 3 years | PII |
Consent Management:
Consent Flow:
1. User lands on signup page
2. Pre-checked boxes: NONE (explicit consent required)
3. User checks boxes for:
โโโ Required: Terms of Service, Privacy Policy
โโโ Optional: Marketing emails (separate opt-in)
โโโ Optional: Analytics cookies (separate opt-in)
4. Record consent: timestamp, IP, version of terms
5. Allow consent withdrawal: Account settings โ Privacy
Consent Storage:
โโโ Database: User_id, consent_type, granted (boolean), timestamp, IP, terms_version
โโโ Logs: Immutable audit trail
โโโ Backup: Encrypted backups with same retention as user data
Data Subject Rights Implementation:
Right to Access:
โโโ User Portal: Download all your data (JSON format)
โโโ Timeline: Automated, instant download
โโโ Contents: All personal data, usage history, consent records
โโโ Implementation: API endpoint + UI
Right to Deletion:
โโโ User Portal: "Delete my account" button
โโโ Timeline: Immediate anonymization, full deletion in 30 days
โโโ Exceptions: Legal hold, fraud prevention (7 days), financial (7 years)
โโโ Implementation: Automated job, cascading deletes
โโโ Confirmation: Email confirmation of deletion
Right to Portability:
โโโ User Portal: Export data in machine-readable format (JSON, CSV)
โโโ Timeline: Instant download
โโโ Implementation: API endpoint
Right to Object:
โโโ Marketing Opt-Out: Unsubscribe link in all emails
โโโ Analytics Opt-Out: Cookie consent banner
โโโ Implementation: Preference center
Data Retention Policy:
| Data Type | Retention Period | Deletion Method | Reason |
|-----------|------------------|-----------------|--------|
| Account data | Account lifetime + 1 year | Automated deletion | Legal compliance |
| Payment records | 7 years | Encrypted archive | Tax/legal |
| Usage analytics | 2 years | Automated deletion | Business need |
| Anonymized data | Indefinite | N/A - de-identified | Analytics |
Breach Response Protocol:
Detection:
โโโ Monitoring: Automated alerts on unusual data access
โโโ Reporting: Employee hotline for suspected breaches
โโโ Logging: Comprehensive access logs
Response Timeline:
โโโ Hour 0: Breach detected, assemble response team
โโโ Hour 4: Contain breach, assess scope
โโโ Hour 12: Notify leadership, engage legal counsel
โโโ Hour 24: Determine notification requirements
โโโ Hour 48: Prepare notifications (regulator, customers, media if >500 affected)
โโโ Hour 72: Submit regulator notifications (GDPR requirement)
โโโ Week 1: Public communication, offer credit monitoring if warranted
Response Team:
โโโ Incident Commander: CTO
โโโ Legal: General Counsel or external counsel
โโโ Communications: CEO or PR lead
โโโ Technical: Lead Engineer
โโโ Compliance: Privacy Officer or DPO
Privacy Policy Requirements:
Must Include:
โโโ Data collected and why
โโโ Legal basis for processing (consent, contract, legitimate interest)
โโโ Data retention periods
โโโ Third-party sharing (subprocessors)
โโโ Data subject rights and how to exercise
โโโ Contact information (email, DPO if EU)
โโโ Cookie policy (if applicable)
โโโ Last updated date
Review Frequency: Annually or when processing changes
Vendor Management:
Data Processors (Subprocessors):
โโโ AWS: Hosting (DPA signed, BAA if healthcare)
โโโ Stripe: Payments (PCI-DSS compliant, DPA signed)
โโโ Sendgrid: Emails (DPA signed)
โโโ Mixpanel: Analytics (DPA signed, data minimization configured)
Due Diligence Checklist:
- [ ] Vendor has SOC 2 or ISO 27001 certification
- [ ] Data Processing Agreement (DPA) signed
- [ ] Vendor's privacy policy reviewed
- [ ] Data location confirmed (EU data stays in EU for GDPR)
- [ ] Subprocessor list reviewed
- [ ] Annual vendor audit scheduled
Implementation Checklist:
Engineering:
- [ ] Consent management system built
- [ ] Data deletion API implemented
- [ ] Data export API implemented
- [ ] Anonymization scripts written
- [ ] Breach detection monitoring deployed
Legal:
- [ ] Privacy policy drafted and reviewed
- [ ] Data Processing Agreements with vendors
- [ ] Terms of Service updated
- [ ] Employee privacy training materials
- [ ] Data breach response plan documented
Product:
- [ ] Consent UI designed and implemented
- [ ] Privacy settings in user account
- [ ] Cookie consent banner (if needed)
- [ ] Unsubscribe links in all emails
- [ ] Data export/deletion flows in product
Estimated Cost: $50K-$100K (legal + engineering + ongoing)
Timeline: 8-12 weeks for full implementation
Track regulatory changes, conduct audits, and maintain compliance over time.
Workflow:
Track Regulatory Changes
Conduct Regular Audits
Maintain Documentation
Update Compliance Program
Output Template:
Compliance Monitoring Dashboard
Regulatory Change Tracking:
Monitoring Sources:
โโโ Agency Newsletters: [FDA, FTC, State AGs] - Weekly review
โโโ Legal Platforms: [Compliance.ai, OneTrust] - Automated alerts
โโโ Law Firm Updates: [Firm name] - Monthly newsletter
โโโ Industry Groups: [Association name] - Quarterly meetings
Recent Changes (Last Quarter):
1. [Regulation/Policy Change]
โโโ Effective Date: [Date]
โโโ Impact: [High/Medium/Low]
โโโ Action Required: [What must change]
โโโ Deadline: [When to comply]
โโโ Owner: [Who's responsible]
2. [Change]...
Upcoming Changes (Next 6 Months):
- [Date]: [Regulation] takes effect - [Action required]
- [Date]: [Regulation] takes effect - [Action required]
Audit Schedule:
Quarterly Internal Audits:
โโโ Q1: [Month] - Data privacy practices
โโโ Q2: [Month] - Vendor compliance
โโโ Q3: [Month] - Security controls
โโโ Q4: [Month] - Employee training completion
Annual External Audits:
โโโ SOC 2 Type II: [Month] - [Auditor]
โโโ Penetration Test: [Month] - [Security firm]
โโโ Cost: $X
Last Audit Findings:
High Priority (Must Fix):
- [Finding]: [Remediation plan, deadline]
- [Finding]: [Remediation plan, deadline]
Medium Priority (Should Fix):
- [Finding]: [Remediation plan, deadline]
Low Priority (Nice to Fix):
- [Finding]: [Remediation plan]
Documentation Maintenance:
| Document | Last Updated | Review Frequency | Next Review | Owner |
|----------|--------------|------------------|-------------|-------|
| Privacy Policy | [Date] | Annually | [Date] | Legal |
| Security Policy | [Date] | Annually | [Date] | CTO |
| Breach Response | [Date] | Annually | [Date] | Legal + CTO |
| Employee Training | [Date] | Annually | [Date] | HR |
Training Program:
New Employee Onboarding:
โโโ Privacy & Security Training: Day 1
โโโ Role-Specific Training: Week 1
โโโ Compliance Quiz: Week 1 (must pass 80%)
โโโ Acknowledgment: Sign policy acceptance
Annual Refresher:
โโโ All Employees: [Month] annually
โโโ Format: Online modules + quiz
โโโ Topics: Privacy, security, compliance updates
โโโ Tracking: HR system records completion
Compliance Metrics:
| Metric | Current | Target | Trend |
|--------|---------|--------|-------|
| Training Completion | 95% | 100% | โ |
| Audit Findings (High) | 2 | 0 | โ |
| Breach Incidents | 0 | 0 | โ |
| Privacy Requests | 5/mo | <10/mo | โ |
| Vendor DPAs Signed | 90% | 100% | โ |
Alert Thresholds:
โโโ Critical: Data breach, regulator inquiry โ Immediate escalation to CEO + Legal
โโโ High: Audit finding (high severity) โ 48-hour response required
โโโ Medium: New regulation applicable โ 30-day assessment required
โโโ Low: Vendor non-compliance โ 90-day remediation
Annual Compliance Budget:
โโโ Legal Counsel: $X (retainer + ad hoc)
โโโ External Audits: $X (SOC 2, pentests)
โโโ Compliance Tools: $X (software subscriptions)
โโโ Training: $X (platforms, materials)
โโโ Insurance: $X (cyber liability, D&O)
โโโ Total: $X/year
Required:
business_model: What you're building, how you make moneyjurisdictions: Where you operate (US states, countries)data_types_collected: PII, PHI, financial data, children's dataindustry_vertical: Healthcare, finance, education, etc.Optional:
current_stage: Pre-launch, launched, scalingexisting_compliance: What's already in placebudget: Available budget for complianceExample Input:
{
"business_model": "B2C telehealth platform connecting patients with licensed therapists",
"jurisdictions": ["United States", "Canada"],
"data_types_collected": ["PII", "PHI", "payment information"],
"industry_vertical": "Healthcare"
}
{
"compliance_requirements": [
{
"regulation": "HIPAA",
"deadline": "Before launch",
"cost": 75000
},
{
"regulation": "State telehealth licenses",
"deadline": "Per state entry",
"cost": 5000
}
],
"licenses_needed": [
{
"license": "Business Associate Agreement with providers",
"jurisdiction": "Federal (HIPAA)",
"timeline": "4 weeks"
}
],
"data_privacy": {
"frameworks": ["HIPAA", "CCPA"],
"implementation": {
"consent_flow": "Explicit opt-in for PHI sharing",
"retention": "PHI retained 7 years per HIPAA",
"breach_protocol": "72-hour notification to HHS"
}
},
"risk_areas": [
{
"area": "Unauthorized PHI disclosure",
"severity": "H",
"mitigation": "Encryption at rest and in transit, access controls, audit logs"
}
],
"ongoing_obligations": [
{
"obligation": "Annual HIPAA risk assessment",
"frequency": "Annually",
"owner": "Compliance Officer"
}
],
"legal_structure": {
"recommended": "Delaware C-Corp",
"rationale": "Standard for US healthcare startups, investor-friendly"
}
}
market-intelligence: Target markets inform jurisdiction requirements business-model: Revenue model informs licensing needs execution: Product features determine data privacy requirements
execution: Compliance requirements become product requirements funding: Compliance readiness affects investor confidence business-model: Compliance costs affect financial projections
This agent navigates regulatory complexity, enabling compliant operations without sacrificing velocity.